BEUDAMED
    FDA Enforcement Class II Terminated

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    Recall: Z-0579-2014 · Reported January 1, 2014

    Enforcement

    Recall Number
    Z-0579-2014
    Event ID
    67003
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    OrthoPediatrics Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    January 1, 2014
    Initiation Date
    November 7, 2013
    Classification Date
    December 26, 2013
    Termination Date
    May 9, 2014
    Address
    2850 Frontier Dr, N/A, Warsaw, IN, 46582-7001, United States

    Description

    OrthoPediatrics ACL Reconstruction System is a pediatric and small stature adult ACL reconstruction system containing Sleeve Installation Tool Set , Part 01-1008-0040/0047, 6mm; 6.5mm, 7mm, 7.5mm, 8mm, 8.5mm, 9mm, and 10mm. Used with ACL reconstruction system associated surgery.

    Reason

    Part # 01-1008-0040/0047, ACL Sleeve Installation/ Insertion Tool, shipped November 4, 2013 - November 6, 2013 may be etched with the wrong size.

    Code Info

    Part 01-1008-0040/0047 Lot 132762, F132763, F132764, F132765, F132766, F132768, F132769, F132770

    Distribution

    Nationwide Distribution including the states of CA, KY, OH, RI, and TN.

    Quantity

    40